PMID- 20492655
OWN - NLM
STAT- MEDLINE
DCOM- 20100915
LR  - 20221207
IS  - 1475-2840 (Electronic)
IS  - 1475-2840 (Linking)
VI  - 9
DP  - 2010 May 21
TI  - Ezetimibe + simvastatin versus doubling the dose of simvastatin in high 
      cardiovascular risk diabetics: a multicenter, randomized trial (the LEAD study).
PG  - 20
LID - 10.1186/1475-2840-9-20 [doi]
AB  - BACKGROUND: The primary goal of therapy in patients with hypercholesterolemia and 
      coronary heart disease (CHD) is reducing low-density lipoprotein cholesterol 
      (LDL-C). This was a multicenter, randomized, double-blind, double-dummy study in 
      patients with type 2 diabetes mellitus (T2DM). METHODS: Adult patients with T2DM 
      and CHD (N = 93) on a stable dose of simvastatin 20 mg with LDL-C >or= 2.6 mmol/L 
      (100 mg/dL) and <or= 4.1 mmol/L (160 mg/dL) were randomized to ezetimibe 10 mg 
      plus simvastatin 20 mg (EZ + simva 10/20 mg) or simvastatin 40 mg for 6 weeks. 
      Percent change in LDL-C, high-density lipoprotein cholesterol, and triglycerides 
      was assessed. RESULTS: EZ + simva 10/20 mg produced a significantly greater 
      change from treated baseline compared with simvastatin 40 mg in LDL-C (-32.2% vs 
      -20.8%; p < 0.01) and total cholesterol (-20.6% vs -13.2%; p < 0.01). A greater 
      proportion of patients achieved LDL-C < 2.6 mmol/L with EZ + simva 10/20 mg than 
      with simvastatin 40 mg, but this was not statistically significant (78.4% vs 60%; 
      odds ratio = 2.81; p = 0.052). Changes in high-density lipoprotein cholesterol 
      and triglycerides were similar between treatments. Both treatments were generally 
      well-tolerated. CONCLUSIONS: These results demonstrate that EZ + simva 10/20 mg 
      may provide a superior alternative for LDL-C lowering vs doubling the dose of 
      simvastatin to 40 mg in hyperlipidemic patients with T2DM and CHD. In addition, 
      the combination therapy may provide an alternative treatment for patients who 
      require further LDL-C reduction than they can achieve with simvastatin 20 mg 
      alone.
FAU - Bardini, Gianluca
AU  - Bardini G
AD  - Department of Clinical Pathophysiology, University of Florence, Florence, Italy.
FAU - Giorda, Carlo B
AU  - Giorda CB
FAU - Pontiroli, Antonio E
AU  - Pontiroli AE
FAU - Le Grazie, Cristina
AU  - Le Grazie C
FAU - Rotella, Carlo M
AU  - Rotella CM
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100521
PL  - England
TA  - Cardiovasc Diabetol
JT  - Cardiovascular diabetology
JID - 101147637
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Azetidines)
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Cholesterol, HDL)
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Drug Combinations)
RN  - 0 (Ezetimibe, Simvastatin Drug Combination)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Triglycerides)
RN  - 0 (hemoglobin A1c protein, human)
RN  - AGG2FN16EV (Simvastatin)
SB  - IM
MH  - Aged
MH  - Anticholesteremic Agents/*administration & dosage
MH  - Azetidines/*administration & dosage
MH  - Biomarkers/blood
MH  - Blood Glucose/metabolism
MH  - Cholesterol, HDL/blood
MH  - Cholesterol, LDL/blood
MH  - Coronary Disease/blood/*drug therapy
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Ezetimibe, Simvastatin Drug Combination
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*administration & dosage
MH  - Hypercholesterolemia/blood/*drug therapy
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Odds Ratio
MH  - Risk Assessment
MH  - Risk Factors
MH  - Simvastatin/*administration & dosage
MH  - Time Factors
MH  - Treatment Outcome
MH  - Triglycerides/blood
PMC - PMC2887787
EDAT- 2010/05/25 06:00
MHDA- 2010/09/16 06:00
PMCR- 2010/05/21
CRDT- 2010/05/25 06:00
PHST- 2010/02/15 00:00 [received]
PHST- 2010/05/21 00:00 [accepted]
PHST- 2010/05/25 06:00 [entrez]
PHST- 2010/05/25 06:00 [pubmed]
PHST- 2010/09/16 06:00 [medline]
PHST- 2010/05/21 00:00 [pmc-release]
AID - 1475-2840-9-20 [pii]
AID - 10.1186/1475-2840-9-20 [doi]
PST - epublish
SO  - Cardiovasc Diabetol. 2010 May 21;9:20. doi: 10.1186/1475-2840-9-20.